On 5 April 2025, at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases held in Vienna, Austria, during a symposium entitled “Advances in AD drug development 02”, Anavex Life Sciences presented further data from its open-label extension of a Phase II/III ATTENTION-AD study (NCT03790709) evaluating blarcamesine for the treatment of early Alzheimer’s disease, mild cognitive impairment and mild Alzheimer’s. The presented findings suggested that the earlier that blarcamesine treatment is initiated, the better the outcomes are for patients over a long period.
Blarcamesine is an oral small molecule that is a sigma 1 receptor agonist. This novel mechanism of action targets Alzheimer’s pathology upstream of amyloid and tau pathology, providing neuroprotective effects. The data presented demonstrated the continued efficacy of blarcamesine at 192 weeks of treatment. The data also showed a significant difference between patients who received blarcamesine throughout the whole duration of the trial and patients who began blarcamesine treatment late, having been in the placebo arm for the first 48 weeks during the double-blind phase of the trial. A significant difference between study arms was seen across cognition, as measured by Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13), and function, measured by Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL).
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Long-term safety data, after 192 weeks of blarcamesine treatment, reaffirmed the benign safety profile of the drug, with no new treatment-emergent adverse events. Blarcamesine is not associated with amyloid-related imaging abnormalities and the most common adverse event seen in the initial trial period, which was dizziness, was reduced in the open-label part of the trial following an extended titration period (10 weeks versus two to three weeks), demonstrating that the dizziness can be easily managed.
A significant opportunity exists for blarcamesine, with its convenient oral dosing and favourable safety profile. This is particularly apparent in Europe where both Eisai/Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab) are yet to be approved by the European Medicines Agency (EMA), with concerns around safety a key challenge for both applications. Anavex’s marketing authorisation application for blarcamesine was accepted by the EMA in December 2024. Blarcamesine therefore has the potential to establish itself in the European market as a first-choice disease-modifying therapy for Alzheimer’s.
